Z-0187-2027 Class II Ongoing
FDA device recall Z-0187-2027 was initiated by Merit Medical Systems, Inc. on Aug 27, 2026 and is designated Class II. Reason for recall: The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use. The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 21, 2026
- Initiation Date
- Aug 27, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01 Contents: (1) Scout MD Delivery System, Standard for use with the SCOUT MD Surgical Guidance System, Rx Only, Sterile-EO
Reason for Recall
The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use.
Distribution Pattern
US: AZ, CA, FL, IN, LA, NV, RI OUS: None
Code Information
MDS05A-01-Lot: H3515477/UDI:00884450392850; MDS05C-01 - Lot: H3507786/UDI:00884450392874; MDS10C-01 - Lot:H3507794/UDI:00884450392911
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0187-2027
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026